Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
LEVONORGESTREL
Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary
G02BA03
LEVONORGESTREL 52 mg
INTRAUTERINE DELIVERY SYSTEM
LEVONORGESTREL 52 mg
POM
OTHER GYNECOLOGICALS
Authorised
2015-02-23
1 PACKAGE LEAFLET Page 2 of 17 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOSERT 20 MICROGRAMS/24 HOURS INTRAUTERINE DELIVERY SYSTEM levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levosert is and what it is used for 2. What you need to know before you use Levosert 3. How to use Levosert 4. Possible side effects 5. How to store Levosert 6. Contents of the pack and other information 1. WHAT LEVOSERT IS AND WHAT IT IS USED FOR Levosert is an intrauterine delivery system (IUS) for insertion in the womb (uterus), where it slowly releases the hormone levonorgestrel. It is used for: _Contraception _ Levosert is an effective, long-term and non-permanent (reversible) method of contraception. Levosert prevents pregnancy by thinning the lining of your womb (uterus), by making the normal mucus in the opening of the womb (cervical canal) thicker, so that the sperm cannot get through to fertilise the egg and by preventing the release of eggs (ovulation) in some women. Furthermore, the presence of the T- shaped frame causes local effects on the lining of the womb. Levosert should be removed after 6 years of use when used for contraception. _Treating heavy menstrual bleeding _ Levosert is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy menstrual bleeding (periods). This is called menorrhagia. The hormone in Levosert acts by thinning the lining of your uterus so that there is less bleeding every month. Levosert should be removed or exchanged after 6 years of use, or earlier if heavy or bothersome menstrual bleeding returns. _Children and adolescents _ Levosert is not indicated for use before the first m Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS _ _ 1. NAME OF THE MEDICINAL PRODUCT Levosert 20 micrograms/24 hours Intrauterine Delivery System 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is levonorgestrel. The intrauterine delivery system contains 52 mg levonorgestrel. The initial release of levonorgestrel is approximately 20 micrograms per day and declines progressively by about 60% after 6 years. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intrauterine delivery system (IUS). The product consists of an inserter and levonorgestrel IUS, which is loaded at the tip of the inserter. Inserter components are an insertion tube, plunger, flange, body and slider. The device consists of a white or almost white hormone-elastomer core, mounted on a T-body and covered in opaque tubing, which regulates the release of levonorgestrel. The T-body has a loop at the end of the vertical stem and two horizontal arms at the other end. Removal threads are attached to the loop. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception. Treatment of heavy menstrual bleeding. Levosert may be particularly useful in women with heavy menstrual bleeding requiring (reversible) contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Starting treatment _ In women of fertile age, Levosert is inserted into the uterine cavity within seven days of the onset of menstruation. It can be replaced by a new system at any time of the cycle. _Postpartum insertion:_ To reduce the risk of perforation, postpartum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six weeks after delivery. If the patient is experiencing significant postpartum bleeding and/or pain then infection or other causes should be excluded before insertion. Levosert can also be inserted immediately after the first trimester abortion. Levosert is effective for six years in the indication contraception and has a demonstrated efficacy for 3 years for the indication heavy menstrual bleeding. Therefor Izlasiet visu dokumentu